Events

Retiro De Equipo (Recall) de Device Recall TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por SPINEART SA.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0336-2018
  • Fecha de inicio del evento
    2017-11-27
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160049
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Causa
    Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
  • Acción
    Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following: "Out of an abundance of caution", we have decided to recall the concerned products. Please carefully follow instructions detailed below: 1. Immediately examine your inventory and quarantine product subject to recall. 2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com." For further questions, please call (949) 313-6400..

Device

Device Recall TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW
  • Modelo / Serial
    batch: 3-8869, 3-5933
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the state of : CA
  • Descripción del producto
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 || TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
  • Manufacturer
    SPINEART SA

Manufacturer

SPINEART SA
  • Dirección del fabricante
    SPINEART SA, route de Pre bois 20, Case Postale 1813, Geneva 15 Switzerland
  • Empresa matriz del fabricante (2017)
    Spineart Sa
  • Source
    USFDA